Pharmaceutical and Medical Device Litigation

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Pharmaceutical and Medical Device Litigation covers how cases develop and are consolidated for pretrial discovery in multidistrict litigation (MDL). It includes a detailed discussion of the strategies and techniques of litigating a major drug or medical device case. You'll find sophisticated endgame strategies, as well as discussions on:

• Federal preemption issues

• The state of class actions after the Class Action Fairness Act of 2005

The author uses pretrial orders from the Baycol and Vioxx MDL cases to illustrate motion practice.

Summary of contents

Part I FDA and Recalls; How Claims Develop
Chapter
1. Overview of the Federal Drug Administration
2. FDA Post-Approval Oversight of Drugs and Devices
3. Drug and Device Advertising
4. The Guidant Experience: Lessons of a Recall, A Case Study
Part II Litigating Multiple Claims
1. Multiple Claims and the MDL Process
2. State and Federal Coordination
3. How the MDL Court and Counsel Organize for an MDL Mass Tort
4. MDL Funding and Expense Sharing
5. Role of the Court as Manager
6. Role of the Plaintiff and Defendant Steering Committees
7. Co-Counsel and Plaintiff Communication
8. Case Themes and Clear Writing
9. Discovery: Finding out What Really Happened
10. The Pre-Trial Orders (PTO)
11. Motion Practice
Part III. Finding Resolution
1. Class Actions in Drug And Device Litigation
2. Trial Selection and Early Trials
3. End Game